Job Title: Drug Safety Specialist
Location: Waltham, MA
Company: Precision Life Science
Position Overview:
We are seeking a detail-oriented and proactive Drug Safety Specialist to join our Pharmacovigilance team in Waltham, MA. The Drug Safety Specialist will be responsible for the collection, assessment, and reporting of adverse events (AEs) and ensuring compliance with global regulatory requirements. This role will support safety operations across clinical trials and marketed products, contributing to patient safety and regulatory obligations.
Key Responsibilities:
Process and evaluate individual case safety reports (ICSRs) from clinical trials, spontaneous sources, and literature.
Conduct case intake, data entry, narrative writing, MedDRA coding, and quality control of safety reports.
Perform timely and accurate adverse event assessments including seriousness, causality, and expectedness.
Prepare and submit expedited and periodic safety reports (e.g., SUSARs, DSURs, PADERs) to regulatory authorities and business partners.
Maintain compliance with global pharmacovigilance regulations, company SOPs, and project timelines.
Collaborate with clinical teams, regulatory affairs, and external partners to ensure robust safety data collection and reporting.
Support signal detection activities and safety data reviews under guidance of senior safety personnel.
Assist in audits, inspections, and responses to Health Authority inquiries.
Contribute to continuous improvement of safety processes and training materials.
Qualifications:
Bachelor’s degree in life sciences, nursing, pharmacy, or a related field (Master’s degree preferred).
2-4 years of experience in pharmacovigilance or drug safety within the pharmaceutical, biotech, or CRO industry.
Strong understanding of global regulatory requirements (FDA, EMA, ICH guidelines) for pharmacovigilance.
Experience with safety databases (e.g., Argus, ARISg, or similar).
Familiarity with MedDRA coding and narrative writing.
Excellent attention to detail, organizational skills, and ability to manage multiple priorities.
Strong written and verbal communication skills.
Ability to work both independently and collaboratively in a team environment.
Preferred Qualifications:
Experience supporting both clinical trial and post-marketing safety activities.
Prior involvement in safety aggregate report preparation (DSURs, PADERs, PSURs).
Knowledge of signal detection methodologies.
Experience in audit and inspection readiness.
Employment Type: Contract
Location Type: Onsite (Waltham, MA) / Hybrid (if applicable)
Compensation: Competitive salary with comprehensive benefits package.